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Author Haiyun Fan

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Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials.

Brian G Feagan, Reena Khanna, William J Sandborn, Séverine Vermeire, Walter Reinisch, Chinyu Su, Leonardo Salese, Haiyun Fan, Jerome Paulissen, Deborah A Woodworth, Wojciech Niezychowski, Bruce E Sands,

<h4>Background</h4>Endoscopy is routine in trials of ulcerative colitis therapies.<h4>Aim</h4>To investigate agreement between central and local Mayo endoscopic subscore (MES) reads in the OCTAVE programme METHODS: Flexible sigmoidoscopy was performed in tofacitinib induction (OCTAVE Induction 1&2, NCT01465763 and NCT01458951), maintenance (OCTAVE Sustain, NCT01458574) and open-label, long-term extension (OCTAVE Open, NCT01470612) studies. ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2021, :]

Cited: 0 times

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Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies.

Marla C Dubinsky, Marco DiBonaventura, Haiyun Fan, Andrew G Bushmakin, Joseph C Cappelleri, Eric Maller, Andrew J Thorpe, Leonardo Salese, Julian Panés,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC.<h4>Methods</h4>Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(7):983-993]

Cited: 1 time

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Letter: thromboembolic and cardiovascular events with tofacitinib in ulcerative colitis-two cases in real world clinical practice. Authors' reply.

William J Sandborn, Julian Panés, Bruce E Sands, Walter Reinisch, Chinyu Su, Nervin Lawendy, Nana Koram, Haiyun Fan, Thomas V Jones, Irene Modesto, Daniel Quirk, Silvio Danese,

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2020, 51(11):1209-1210]

Cited: 0 times

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Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis.

Jeffrey Kaine, John Tesser, Liza Takiya, Ryan DeMasi, Lisy Wang, Mark Snyder, Koshika Soma, Haiyun Fan, Vara Bandi, Jürgen Wollenhaupt,

<h4>Introduction/objective</h4>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post-hoc analysis evaluated the effect of temporary discontinuation and reinitiation of tofacitinib on disease control in patients with RA in the vaccine sub-study of the long-term extension (LTE) study ORAL Sequel (NCT00413699).<h4>Methods</h4>The sub-study of ORAL ... Read more >>

Clin Rheumatol (Clinical rheumatology)
[2020, 39(7):2127-2137]

Cited: 2 times

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Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme.

William J Sandborn, Julian Panés, Bruce E Sands, Walter Reinisch, Chinyu Su, Nervin Lawendy, Nana Koram, Haiyun Fan, Thomas V Jones, Irene Modesto, Daniel Quirk, Silvio Danese,

<h4>Background</h4>Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC).<h4>Aim</h4>To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme.<h4>Methods</h4>DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2019, 50(10):1068-1076]

Cited: 29 times

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Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study.

Yoshiya Tanaka, Naonobu Sugiyama, Shigeyuki Toyoizumi, Tatjana Lukic, Manisha Lamba, Richard Zhang, Connie Chen, Thomas Stock, Hernan Valdez, Christopher Mojcik, Haiyun Fan, Chenhui Deng, Hirotoshi Yuasa,

Objective:Tofacitinib is an oral Janus kinase inhibitor for treatment of RA. We compared tofacitinib modified-release (MR) 11 mg once daily (QD) with tofacitinib immediate-release (IR) 5 mg twice daily (BID) in Japanese patients with RA and inadequate response to MTX. Methods:Phase III, randomized, double-blind, double-dummy, 12-week study. Patients were randomized ... Read more >>

Rheumatology (Oxford) (Rheumatology (Oxford, England))
[2019, 58(1):70-79]

Cited: 4 times

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A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population.

Alan J Kivitz, Stanley Cohen, Edward Keystone, Ronald F van Vollenhoven, Boulos Haraoui, Jeffrey Kaine, Haiyun Fan, Carol A Connell, Eustratios Bananis, Liza Takiya, Roy Fleischmann,

<h4>Objective</h4>This post-hoc, pooled analysis of Phase 3 studies of tofacitinib examined the safety of tofacitinib 5 and 10 mg twice daily (BID) when used as monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with rheumatoid arthritis (RA).<h4>Methods</h4>Pooled data from six double-blind, randomized controlled Phase 3 studies ... Read more >>

Semin Arthritis Rheum (Seminars in arthritis and rheumatism)
[2018, 48(3):406-415]

Cited: 9 times

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Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis.

Roy Fleischmann, Jürgen Wollenhaupt, Stanley Cohen, Lisy Wang, Haiyun Fan, Vara Bandi, John Andrews, Liza Takiya, Eustratios Bananis, Michael E Weinblatt,

INTRODUCTION:Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the effect of concomitant methotrexate (MTX) or glucocorticoid (GC) use on tofacitinib clinical efficacy. METHODS:Data were pooled from two open-label, long-term extension studies of tofacitinib 5 or 10 mg twice daily in patients with RA. ... Read more >>

Rheumatol Ther (Rheumatology and therapy)
[2018, 5(1):203-214]

Cited: 3 times

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Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies.

Christina Charles-Schoeman, Désirée van der Heijde, Gerd R Burmester, Peter Nash, Cristiano A F Zerbini, Carol A Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis, Roy Fleischmann,

OBJECTIVE:Tofacitinib has been investigated for the treatment of rheumatoid arthritis (RA) in phase III studies in which concomitant glucocorticoids (GC) were allowed. We analyzed the effect of GC use on efficacy outcomes in patients with RA receiving tofacitinib and/or methotrexate (MTX) or conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in these ... Read more >>

J Rheumatol (The Journal of rheumatology)
[2018, 45(2):177-187]

Cited: 7 times

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Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

Stanley Cohen, Jeffrey R Curtis, Ryan DeMasi, Yan Chen, Haiyun Fan, Arif Soonasra, Roy Fleischmann,

<h4>Introduction</h4>Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting.<h4>Methods</h4>Worldwide tofacitinib PMS ... Read more >>

Rheumatol Ther (Rheumatology and therapy)
[2018, 5(1):283-291]

Cited: 21 times

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Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy.

Kevin L Winthrop, Jeffrey R Curtis, Stephen Lindsey, Yoshiya Tanaka, Kunihiro Yamaoka, Hernan Valdez, Tomohiro Hirose, Chudy I Nduaka, Lisy Wang, Alan M Mendelsohn, Haiyun Fan, Connie Chen, Eustratios Bananis,

<h4>Objective</h4>Patients with rheumatoid arthritis (RA) are at increased risk of herpes zoster (HZ), and the risk appears to be increased in patients treated with tofacitinib. The aim of this study was to evaluate whether concomitant treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or glucocorticoids (GCs) contributes to the increased ... Read more >>

Arthritis Rheumatol (Arthritis & rheumatology (Hoboken, N.J.))
[2017, 69(10):1960-1968]

Cited: 66 times

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Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies.

Ruben Burgos-Vargas, Mario Cardiel, Daniel Xibillé, César Pacheco-Tena, Virginia Pascual-Ramos, Carlos Abud-Mendoza, Ehab Mahgoub, Mahboob Rahman, Haiyun Fan, Ricardo Rojo, Erika García, Karina Santana,

<h4>Objectives</h4>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies.<h4>Methods</h4>Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from ... Read more >>

Reumatol Clin (Engl Ed) (Reumatologia clinica)
[2019, 15(1):43-53]

Cited: 0 times

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Analysis of non-melanoma skin cancer across the tofacitinib rheumatoid arthritis clinical programme.

Jeffrey R Curtis, Eun Bong Lee, George Martin, Xavier Mariette, Ketti K Terry, Yan Chen, Jamie Geier, John Andrews, Mandeep Kaur, Haiyun Fan, Chudy I Nduaka,

<h4>Objectives</h4>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the incidence of non-melanoma skin cancer (NMSC) across the tofacitinib RA development programme.<h4>Methods</h4>NMSC events (through August 2013) were identified in patients receiving tofacitinib in two Phase (P)1, eight P2, six P3 and two long-term ... Read more >>

Clin Exp Rheumatol (Clinical and experimental rheumatology)
[2017, 35(4):614-622]

Cited: 9 times

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The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis.

Kevin L Winthrop, Joel Silverfield, Arthur Racewicz, Jeffrey Neal, Eun Bong Lee, Pawel Hrycaj, Juan Gomez-Reino, Koshika Soma, Charles Mebus, Bethanie Wilkinson, Jennifer Hodge, Haiyun Fan, Tao Wang, Clifton O Bingham,

<h4>Objective</h4>To evaluate tofacitinib's effect upon pneumococcal and influenza vaccine immunogenicity.<h4>Methods</h4>We conducted two studies in patients with rheumatoid arthritis using the 23-valent pneumococcal polysaccharide vaccine (PPSV-23) and the 2011-2012 trivalent influenza vaccine. In study A, tofacitinib-naive patients were randomised to tofacitinib 10 mg twice daily or placebo, stratified by background methotrexate and ... Read more >>

Ann Rheum Dis (Annals of the rheumatic diseases)
[2016, 75(4):687-695]

Cited: 63 times

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